Stump NeuromaNCT07431424
Ultrasound-Guided Radiofrequency Ablation Versus Steroid Injection for Stump Neuroma
A study testing Radiofrequency ablation alone and Corticosteroid Injection in people with Stump Neuroma and Residual Limb Pain, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective clinical study aims to compare the effectiveness of ultrasound-guided radiofrequency ablation and ultrasound-guided corticosteroid injection in individuals with symptomatic stump neuroma following lower extremity amputation. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Stump Neuroma, Residual Limb Pain, Lower Extremity Amputation
- What is being tested?
- Radiofrequency ablation alone and Corticosteroid Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Jan 2023to 4 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants aged 18 to 65 years.
- Unilateral or bilateral traumatic lower extremity amputation.
- Amputation level: transfemoral, transtibial, or Syme amputation.
- Residual limb pain with a VAS score ≥ 4.
- Willing and able to provide informed consent.
- No injection to the distal stump and no surgery targeting the stump within the past 3 months.
Who cannot join
- Unwilling or unable to provide informed consent.
- Conditions in which radiofrequency ablation and/or steroid injection are contraindicated, including inflamed or infected skin, impaired skin integrity at the procedure site, active bleeding at the site, unstable epilepsy or unexplained seizure history, uncontrolled diabetes mellitus, unstable acute cardiac arrhythmia or heart failure, or presence of a cardiac pacemaker.
- History of allergy to the injected medications (e.g., local anesthetics and/or corticosteroids).
- Psychiatric disorder or cognitive impairment that would prevent completion of study questionnaires.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziler Physical Medicine and Rehabilitation Training and Research Hospital
Ankara, Ankara, 06800
About this study
Official title: A Prospective Comparative Study of Ultrasound-Guided Radiofrequency Ablation and Steroid Injection in Individuals With Lower Extremity Amputation and Symptomatic Stump Neuroma
This prospective clinical study aims to compare the effectiveness of ultrasound-guided radiofrequency ablation and ultrasound-guided corticosteroid injection in individuals with symptomatic stump neuroma following lower extremity amputation. Stump neuroma is a common cause of residual limb pain and may significantly impair mobility and quality of life.
Participants undergoing either treatment will be evaluated prospectively. Pain intensity, neuropathic pain characteristics, functional mobility, socket comfort, sleep quality, and neuroma size measured by ultrasound will be assessed during follow-up. The study seeks to provide clinical evidence regarding the comparative clinical and radiological outcomes of these two treatment approaches.
Read the detailed description
Lower extremity amputation is frequently associated with persistent residual limb pain. One of the most common causes of residual limb pain is symptomatic stump neuroma, which may lead to functional limitation, reduced prosthetic tolerance, and decreased quality of life. Neuroma-related pain is often described as burning, stabbing, or electric shock-like in nature and may be triggered by mechanical stimulation.
Diagnosis is based on clinical evaluation and imaging methods, particularly ultrasound, which allows visualization of the neuroma as a hypoechoic mass contiguous with the affected peripheral nerve.
Various treatment options have been described for symptomatic neuroma, including pharmacological therapy, physical modalities, steroid injections, ablative procedures, and surgical intervention. Although surgical treatment is considered effective, it may be associated with recurrence, scar formation, and delayed prosthetic rehabilitation. Minimally invasive interventions such as ultrasound-guided corticosteroid injection and radiofrequency ablation have gained increasing attention as alternative treatment options.
Corticosteroid injection is thought to reduce pain through anti-inflammatory effects and stabilization of neural membranes. Radiofrequency ablation uses controlled thermal energy to create targeted nerve lesioning, thereby reducing nociceptive signal transmission.
This prospective clinical study compares the clinical and ultrasonographic outcomes of ultrasound-guided radiofrequency ablation and ultrasound-guided corticosteroid injection in individuals with symptomatic stump neuroma following lower extremity amputation. The primary aim is to evaluate and compare pain reduction, functional improvement, and changes in neuroma size following these two interventional approaches.
- Being tested
- Radiofrequency ablation alone, Corticosteroid Injection
- Keywords
- stump neuroma, residual limb pain, lower extremity amputation, radiofrequency ablation, ultrasound-guided injection, corticosteroid injection, neuroma size
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablation aloneProcedure or surgery
Ultrasound-guided radiofrequency ablation was performed targeting the symptomatic stump neuroma using controlled thermal energy.
Corticosteroid InjectionDrug
Ultrasound-guided corticosteroid injection was administered to the symptomatic stump neuroma for pain relief.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-Guided Radiofrequency Ablation | Experimental | Participants received ultrasound-guided radiofrequency ablation targeting the symptomatic stump neuroma. Receives: Procedure: Radiofrequency ablation alone |
| Ultrasound-Guided Corticosteroid Injection | Experimental | Participants received ultrasound-guided corticosteroid injection for treatment of symptomatic stump neuroma. Receives: Drug: Corticosteroid Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Analog Scale (VAS) Pain Score at Rest From Baseline to 3 Months
Pain intensity at rest measured using a 10-point Visual Analog Scale (0-10), with higher scores indicating greater pain.
Measured: Baseline, 1 Month, and 3 Months
Change in Visual Analog Scale (VAS) Pain Score During Activity From Baseline to 3 Months
Pain intensity during activity measured using a 10-point Visual Analog Scale (0-10), with higher scores indicating greater pain.
Measured: Baseline, 1 Month, and 3 Months
Secondary outcomes (5)
Change in Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Score
Neuropathic pain characteristics assessed using the validated LANSS questionnaire at baseline, 1 month, and 3 months.
Measured: Baseline, 1 Month, and 3 Months
Change in Locomotor Capabilities Index (LCI) Score
Neuroma size assessed by ultrasound imaging at baseline, 1 month, and 3 months.
Measured: Baseline, 1 Month, and 3 Months
Change in Neuroma Long-Axis and Short-Axis Diameter Measured by Ultrasound
Baseline and 3 Months
Measured: Neuroma dimensions (long-axis and short-axis diameters) measured by ultrasound imaging at baseline and 3 months.
Change in Daily Prosthetic Wearing Time
Baseline and 3 Months
Measured: Daily duration of prosthetic use reported in hours per day, assessed at baseline and 3 months. Measured as the average number of hours per day the prosthesis was worn.
Change in Sleep Quality Category
Sleep quality categorized based on participant self-report (e.g., very poor, poor, moderate, good, very good) assessed at baseline and 3 months.
Measured: Baseline and 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start8 Jan 2023
- Primary completion4 Feb 2024
- Study completion4 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stump NeuromaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants were assigned to one of two parallel treatment groups: ultrasound-guided radiofrequency ablation or ultrasound-guided corticosteroid injection. Each participant received a single interventional treatment and was followed prospectively for outcome assessment.
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasin Demir, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07431424
- Sponsor's protocol ID
- E2-23-3126
- Status last verified
- Feb 2026
- First submitted
- 18 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to institutional policies and data protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Comparative Study of Ultrasound-Guided Radiofrequency Ablation and Steroid Injection in Individuals With Lower Extremity Amputation and Symptomatic Stump Neuroma
- ClinicalTrials.gov ID
- NCT07431424
- Acronym / sponsor ID
- E2-23-3126
- Keywords
- stump neuroma, residual limb pain, lower extremity amputation, radiofrequency ablation, ultrasound-guided injection, corticosteroid injection, neuroma size
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
- Study start
- 8 Jan 2023 (actual)
- Primary completion
- 4 Feb 2024 (actual)
- Study completion
- 4 Feb 2024 (actual)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective clinical study aims to compare the effectiveness of ultrasound-guided radiofrequency ablation and ultrasound-guided corticosteroid injection in individuals with symptomatic stump neuroma following lower extremity amputation. Stump neuroma is a common cause of residual limb pain and may significantly impair mobility and quality of life.
Participants undergoing either treatment will be evaluated prospectively. Pain intensity, neuropathic pain characteristics, functional mobility, socket comfort, sleep quality, and neuroma size measured by ultrasound will be assessed during follow-up. The study seeks to provide clinical evidence regarding the comparative clinical and radiological outcomes of these two treatment approaches.
Detailed description
Lower extremity amputation is frequently associated with persistent residual limb pain. One of the most common causes of residual limb pain is symptomatic stump neuroma, which may lead to functional limitation, reduced prosthetic tolerance, and decreased quality of life. Neuroma-related pain is often described as burning, stabbing, or electric shock-like in nature and may be triggered by mechanical stimulation.
Diagnosis is based on clinical evaluation and imaging methods, particularly ultrasound, which allows visualization of the neuroma as a hypoechoic mass contiguous with the affected peripheral nerve.
Various treatment options have been described for symptomatic neuroma, including pharmacological therapy, physical modalities, steroid injections, ablative procedures, and surgical intervention. Although surgical treatment is considered effective, it may be associated with recurrence, scar formation, and delayed prosthetic rehabilitation. Minimally invasive interventions such as ultrasound-guided corticosteroid injection and radiofrequency ablation have gained increasing attention as alternative treatment options.
Corticosteroid injection is thought to reduce pain through anti-inflammatory effects and stabilization of neural membranes. Radiofrequency ablation uses controlled thermal energy to create targeted nerve lesioning, thereby reducing nociceptive signal transmission.
This prospective clinical study compares the clinical and ultrasonographic outcomes of ultrasound-guided radiofrequency ablation and ultrasound-guided corticosteroid injection in individuals with symptomatic stump neuroma following lower extremity amputation. The primary aim is to evaluate and compare pain reduction, functional improvement, and changes in neuroma size following these two interventional approaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were assigned to one of two parallel treatment groups: ultrasound-guided radiofrequency ablation or ultrasound-guided corticosteroid injection. Each participant received a single interventional treatment and was followed prospectively for outcome assessment.
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-Guided Radiofrequency Ablation | Experimental | Procedure: Radiofrequency ablation aloneParticipants received ultrasound-guided radiofrequency ablation targeting the symptomatic stump neuroma. |
| Ultrasound-Guided Corticosteroid Injection | Experimental | Drug: Corticosteroid InjectionParticipants received ultrasound-guided corticosteroid injection for treatment of symptomatic stump neuroma. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants aged 18 to 65 years.
- Unilateral or bilateral traumatic lower extremity amputation.
- Amputation level: transfemoral, transtibial, or Syme amputation.
- Residual limb pain with a VAS score ≥ 4.
- Willing and able to provide informed consent.
Key exclusion criteria (4 listed)
- Unwilling or unable to provide informed consent.
- Conditions in which radiofrequency ablation and/or steroid injection are contraindicated, including inflamed or infected skin, impaired skin integrity at the procedure site, active bleeding at the site, unstable epilepsy or unexplained seizure history, uncontrolled diabetes mellitus, unstable acute cardiac arrhythmia or heart failure, or presence of a cardiac pacemaker.
- History of allergy to the injected medications (e.g., local anesthetics and/or corticosteroids).
- Psychiatric disorder or cognitive impairment that would prevent completion of study questionnaires.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency ablation aloneUltrasound-guided radiofrequency ablation was performed targeting the symptomatic stump neuroma using controlled thermal energy. | Procedure or surgery | Ultrasound-Guided Radiofrequency Ablation |
| Corticosteroid InjectionUltrasound-guided corticosteroid injection was administered to the symptomatic stump neuroma for pain relief. | Drug | Ultrasound-Guided Corticosteroid Injection |
Primary outcome
Change in Visual Analog Scale (VAS) Pain Score at Rest From Baseline to 3 Months
Time frame: Baseline, 1 Month, and 3 Months
Pain intensity at rest measured using a 10-point Visual Analog Scale (0-10), with higher scores indicating greater pain.
Change in Visual Analog Scale (VAS) Pain Score During Activity From Baseline to 3 Months
Time frame: Baseline, 1 Month, and 3 Months
Pain intensity during activity measured using a 10-point Visual Analog Scale (0-10), with higher scores indicating greater pain.
5 secondary outcomes
Change in Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Score
Time frame: Baseline, 1 Month, and 3 Months
Change in Locomotor Capabilities Index (LCI) Score
Time frame: Baseline, 1 Month, and 3 Months
Change in Neuroma Long-Axis and Short-Axis Diameter Measured by Ultrasound
Time frame: Neuroma dimensions (long-axis and short-axis diameters) measured by ultrasound imaging at baseline and 3 months.
Change in Daily Prosthetic Wearing Time
Time frame: Daily duration of prosthetic use reported in hours per day, assessed at baseline and 3 months. Measured as the average number of hours per day the prosthesis was worn.
Change in Sleep Quality Category
Time frame: Baseline and 3 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to institutional policies and data protection regulations.
Related trials for Stump Neuroma
Not yet recruitingObservational study
Comparison Between Digital Nerve Microanastomosis and Traction Neurectomy in Post-Digital Amputation Pain
Amputation Stump, Amputation Neuroma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency ablation alone and Corticosteroid Injection in people with Stump Neuroma and Residual Limb Pain, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual Analog Scale (VAS) Pain Score at Rest From Baseline to 3 Months (time frame: Baseline, 1 Month, and 3 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.